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Norm

ISO 80601-2-69:2014

Issue date: 2014 07 15

Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referre...
Withdrawn: 2020 11 06
Publisher:
International Organization for Standardization
Format:
Digital | 42 Pages
Language:
English

ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.

ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.

ISO 80601-2-69:2020
2020 11 06
Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential...
Norm
ISO 80601-2-69:2014
2014 07 15
Medical electrical equipment — Part 2-69: Particular requirements for basic safety and essential per...
Norm
ISO 8359:1996/Amd 1:2012
2012 06 29
Oxygen concentrators for medical use — Safety requirements — Amendment 1
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ISO 8359:1996
1996 12 05
Oxygen concentrators for medical use — Safety requirements
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ISO 8359:1988
1988 03 03
Oxygen concentrators for medical use — Safety requirements
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Expand
Norm
ISO 80601-2-69:2020
Issue date : 2020 11 06
Medical electrical equipment — Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment